Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

• Sponsor: Entellus Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01612780
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Condition or Disease	Intervention/Treatment	Phase
Sinusitis	Device: XprESS Multi-Sinus Dilation Tool	N/A

Detailed Description

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XprESS Multi-Sinus Dilation Tool Balloon sinus dilation	Device: XprESS Multi-Sinus Dilation Tool; Sinus balloon dilation; Other Names: Sinus balloon dilation

Outcome Measures

Primary Outcome Measures

1. Change in SNOT-20 Score [Baseline and 1-year post procedure]

   The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.

Secondary Outcome Measures

1. Revision Sinus Surgery [1-year post procedure]

   The number of participants who require revision sinus surgery to address continuing sinus symptoms.

2. Number of Participants With Serious Device and/or Procedure-related Adverse Events [Through 1-year post procedure follow-up]

   Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Be at least age 18 years old or older.

2. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.

3. Have a sinus CT scan within 12 months of the procedure date.

4. Be able and willing to provide consent.

5. Be willing to comply with the protocol requirements.

Exclusion Criteria:

1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).

2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.

3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.

4. Have presence of features consistent with sinus fungal disease.

5. Be allergic to nickel or barium sulfate.

6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Entellus Medical	Plymouth	Minnesota	United States	55447

Sponsors and Collaborators

• Entellus Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Entellus Medical patient-facing website about sinusitis

Publications

None provided.

• Responsible Party: Entellus Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01612780
• Other Study ID Numbers: 2233-001
• First Posted: Jun 6, 2012
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Entellus Medical, Inc.: Sinusitis; Sinus balloon dilation patients
• Additional relevant MeSH terms: Sinusitis; Dilatation, Pathologic

Study Results

Participant Flow

Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Period Title: Overall Study
STARTED	82
COMPLETED	76
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Overall Participants	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (16.7)
Sex: Female, Male (Count of Participants)
Female	47 57.3%
Male	35 42.7%
Region of Enrollment (Count of Participants)
United States	82 100%
Type of sinusitis (Count of Participants)
Chronic rhinosinusitis	73 89%
Recurrent acute rhinosinusitis	9 11%
Baseline SNOT-20 score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.27 (0.92)

Outcome Measures

1. Primary Outcome

Title	Change in SNOT-20 Score
Description	The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Time Frame	Baseline and 1-year post procedure

Outcome Measure Data

Analysis Population Description

All participants who had 1 or more sinuses successfully treated with the XprESS device and both baseline and 1-year follow-up SNOT-20 scores available for analysis.

Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Measure Participants	75
Baseline	2.3 (0.92)
1-Year follow-up	0.7 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Balloon Sinus Dilation
	Comments	Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Values of p <0.05 were deemed statistically significant.
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Revision Sinus Surgery
Description	The number of participants who require revision sinus surgery to address continuing sinus symptoms.
Time Frame	1-year post procedure

Outcome Measure Data

Analysis Population Description

All participants with 1 or more sinuses successfully treated with the XprESS device.

Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Measure Participants	81
Count of Participants [Participants]	1 1.2%

3. Secondary Outcome

Title	Number of Participants With Serious Device and/or Procedure-related Adverse Events
Description	Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Time Frame	Through 1-year post procedure follow-up

Outcome Measure Data

Analysis Population Description

All enrolled participants.

Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
Measure Participants	82
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Adverse events were systematically collected by standardized case report forms through 1 year post procedure.
Adverse Event Reporting Description	All SAEs, regardless of relationship to the study device and/or procedure, were reported. The protocol only required nonserious AEs that were classified by the Investigator as device-related and/or procedure-related to be collected.
Arm/Group Title	Balloon Sinus Dilation
Arm/Group Description	Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool
All Cause Mortality
	Balloon Sinus Dilation
	Affected / at Risk (%)	# Events
Total	0/82 (0%)
Serious Adverse Events
	Balloon Sinus Dilation
	Affected / at Risk (%)	# Events
Total	1/82 (1.2%)
Infections and infestations
Tick-borne illness	1/82 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Balloon Sinus Dilation
	Affected / at Risk (%)	# Events
Total	0/82 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.